Clinical Trials
22
2 active
Approvals
10
Total approvals
Agencies
1
Regulatory bodies
Founded
1995
Active, not recruiting
2
9.1%
Completed
16
72.7%
Recruiting
1
4.5%
Unknown
2
9.1%
- Amneal Pharmaceuticals received FDA approval for lanreotide injection 120 mg/0.5 mL in a single-dose prefilled syringe, referencing Ipsen's Somatuline Depot. - The product launched immediately and carries Competitive Generic Therapy designation, supported by Amneal's in-house manufacturing capacity for complex injectables. - Lanreotide is indicated for acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors and carcinoid syndrome, controlling hormone levels and improving progression-free survival in eligible patients. - U.S. annual sales of Somatuline Depot reached $983 million in the 12 months ended July 2026, according to IQVIA data cited by Amneal.
- Amneal Pharmaceuticals completed its acquisition of Kashiv BioSciences, creating a fully integrated biosimilars platform spanning research, development, manufacturing and commercialization. - The deal positions Amneal to pursue more than $300 billion in projected global biologics loss-of-exclusivity opportunities over the next decade. - A biosimilar to Novartis' Xolair remains under FDA review, with a potential launch expected by the end of 2026 if approved, which would bring Amneal's U.S. biosimilar portfolio to six products. - Management has positioned biosimilars as a major long-term growth pillar within the company's Affordable Medicines business, which contributed $1.7 billion, or 57.8% of fiscal 2025 revenues.
- Amneal received FDA approval for four additional generic iohexol injection vial presentations, including 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, and 300 mg iodine/mL in a 50 mL vial. - The newly approved products are the first generic versions referencing OMNIPAQUE across these strengths and vial presentations, with launch expected in Q3 2026. - The expanded portfolio is expected to address the majority of U.S. market demand for iohexol injection, which totaled approximately $706 million in annual sales per IQVIA data. - Iohexol is an iodinated radiographic contrast agent indicated for diagnostic imaging in adults and pediatric patients aged two weeks and older across multiple routes of administration.
- The CHMP adopted a positive opinion recommending EU marketing authorization for Hopledo (modified-release levodopa/carbidopa) in adults with Parkinson's disease and moderate to severe motor fluctuations. - The recommendation is based on the Phase 3 RISE-PD trial, which showed significantly more "Good ON" time with fewer daily doses versus immediate-release levodopa/carbidopa. - Hopledo combines immediate-release granules and extended-release pellets for rapid onset and longer duration of effect, and is already marketed in the U.S. as CREXONT. - Subject to European Commission approval, Zambon expects to begin phased introduction of Hopledo across European markets starting October 2026.
- Amneal Pharmaceuticals agreed to acquire Kashiv BioSciences for $750 million upfront plus up to $350 million in milestone payments to establish a fully integrated global biosimilar platform. - The transaction positions Amneal to capitalize on a projected $300 billion global biologics loss-of-exclusivity opportunity over the next decade. - Amneal reported strong preliminary Q1 2026 results with 4% revenue growth to $723 million and raised full-year guidance, reflecting continued momentum across its diversified portfolio. - The combined entity expects to launch multiple biosimilars annually and have over 12 commercial biosimilars by 2030, with more than 20 additional products in development.
- Amneal's Phase 4 ELEVATE-PD trial demonstrated that CREXONT provided clinically meaningful benefits across all prior treatment groups, with patients gaining 2.91 to 3.40 hours of additional daily "Good On" time after switching from various carbidopa/levodopa therapies. - Patients switching from RYTARY to CREXONT experienced particularly notable improvements, with continuous "Good On" intervals nearly doubling from 3.45 hours to 6.58 hours and daily motor fluctuations reducing by 1.92 episodes. - The interim safety profile showed treatment-emergent adverse events were generally mild to moderate, with the most common being dizziness (9.0%), nausea (7.2%), and falls (7.2%). - CREXONT's novel mucoadhesive polymer technology provides the longest-lasting levodopa plasma levels of any oral carbidopa/levodopa therapy currently available, addressing key patient priorities of extended symptom control and reduced dosing burden.
- Airway Therapeutics appointed Joe Todisco, Chairman and CEO of CorMedix Inc., to its Board of Directors to support the advancement of zelpultide alfa through late-stage development and commercialization preparation. - Todisco brings over two decades of pharmaceutical industry leadership experience, including expertise in hospital channel commercialization where Airway expects to launch its lead product for bronchopulmonary dysplasia (BPD). - Zelpultide alfa is currently in late-stage clinical development for preventing BPD in very preterm infants, a condition with no approved preventive therapies. - The appointment positions Airway Therapeutics for its next growth phase as it prepares to commercialize its platform biologic across multiple disease settings and age groups.
- Amneal Pharmaceuticals announced the launch of bimatoprost ophthalmic solution 0.01%, a generic equivalent to Allergan's LUMIGAN for treating open-angle glaucoma and ocular hypertension. - The prostaglandin analog is available in three vial sizes (2.5 mL, 5 mL, and 7.5 mL) and targets a market with approximately $719 million in annual U.S. sales. - The launch expands Amneal's Affordable Medicines portfolio and addresses the growing prevalence of glaucoma, particularly among aging populations. - The most common adverse reaction associated with the treatment is conjunctival hyperemia, according to prescribing information.
- Amneal Pharmaceuticals has established a manufacturing and supply partnership for GLP-1 therapies through Metsera, which was subsequently acquired by Pfizer. - The collaboration provides Amneal with revenue exposure to the growing GLP-1 market while avoiding clinical development risks associated with drug discovery. - This partnership supports Amneal's strategic shift toward complex injectables, biosimilars, and peptide therapeutics as part of its higher-value product mix. - The company expects to maintain a launch cadence of 20 to 30 new Affordable Medicines products annually, with six biosimilars planned for the U.S. market by 2027.
- The European Patent Office has declared its intention to approve Iconovo's patent application for the ICOpre® inhaler platform, which is designed as a substitutable generic alternative to GSK's Ellipta® inhaler. - ICOpre® features a proprietary dose-administering design with 30 individually sealed doses, a two-compartment system, and precise dose counter, targeting a market worth approximately USD 6 billion in annual sales. - The patent protects unique properties that differentiate ICOpre® from blister strip technologies and is expected to strengthen the company's efforts to secure late-stage development and commercialization partnerships. - Iconovo has previously received positive guidance from the U.S. FDA regarding generic substitutability and potential AB rating for the inhaler platform.
